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Consultation on the International Council for Harmonisation (ICH) E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
The MHRA is consulting with UK stakeholders to gather feedback and comments on a new international guideline for the appropriate inclusion and/or retention of pregnant and/or breast-feeding individuals in clinical trials of medicines.
Common specification requirements for in vitro diagnostic devices
MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.
MHRA issues new guidance for people using mental health apps and technologies
New online resources will help the public, parents, carers and health, social care and education professionals understand what safe, effective digital mental health technologies look like in practice.
MHRA’s 2024–25 Annual Report and Accounts and Impact Report show progress on safety, innovation, and regulatory excellence
The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2024–25 Annual Report and Accounts, and accompanying Impact Report.
Field Safety Notices: 1 to 5 September 2025
List of Field Safety Notices from 1 to 5 September 2025.
MHRA welcomes Professor Jacob George as he starts Chief Medical and Scientific Officer role
In this new role, Professor George will lead the Agency’s science strategy and will oversee the MHRA’s scientific, research and innovation activities.
